Biogen TYSABRI Patents Spared Inter Partes Review

The USPTO Patent Trial and Appeals Board (PTAB) declined to institute Inter Partes Review (IPR) proceedings against three Biogen Idec TYSABRI patents. The IPR petitions were filed by Swiss Pharma International, and asserted obviousness based on references that disclosed antibody formulations similar to those claimed in the Biogen patents, but did not teach the high antibody concentration recited in Biogen’s claims. While Swiss argued that the claimed concentration range represented “nothing more than routine optimization of a result effective variable,” the PTAB disagreed. Instead, the PTAB denied institution because Swiss failed to establish a motivation to increase the antibody concentration in prior art formulations and a reasonable expectation of success in doing so.

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USPTO Makes It Easy To Review Patent Assignment Documents

The USPTO has yet to implement new rules requiring applicants to promptly record patent ownership information, but it recently made it much easier to review patent assignment documents that have been recorded at the USPTO. The USPTO previously provided ownership information on its patent assignment database website, but now provides PDF images of the actual recorded documents–such as executed assignment documents. This is a significant advantage, because it lets the public confirm the ownership information, which the USPTO does not verify, but simply pulls from the recordation cover sheet. Since the USPTO does not provide a standard assignment form, it also could be interesting to see the assignment language different entities use.



Higher US Patent Fees On The Horizon

The USPTO has published a proposed fee schedule for patent fees likely to take effect October 1, 2017–the start of the USPTO’s next fiscal year. The proposed fee schedule makes “slight” changes to many fees, and more “significant” changes to RCE, ex parte appeal, and patent trial fees (among others). Written comments are due by December, 2, 2016. Continue reading this entry

PTAB Upholds Lialda Patent Over Kyle Bass IPR Challenge

The USPTO Patent Trial and Appeal Board (PTAB) has issued a final written decision upholding Shire’s Lialda® patent over the Inter Partes Review (IPR) challenge brought by Kyle Bass and his Coalition for Affordable Drugs. The decision underscores that obviousness is not established simply because each feature of a claim is found somewhere in the prior art where there is inadequate evidence of a motivation to arrive at the claimed invention as a whole.  Continue reading this entry

Judge Grants Gilead Motion To Invalidate Remicade Patent For Obviousness-Type Double Patenting

The FDA approved Inflectra–Celltrion’s biosimilar version of Janssen’s Remicade® (infliximab) product–in April 2016, but according to Pfizer’s press release it’s commercial launch still “depend[s] on a number of factors” including “intellectual property considerations.” The pending biosimilar patent litigation got one step closer to resolution last week when Judge Wolf of the U.S. District Court for the District of Massachusetts granted Celltrion’s “Gilead Motion” for summary judgment of invalidity of U.S. Patent 6,284,471. The court entered final judgment on that patent to expedite Janssen’s ability to pursue an appeal and finally resolve at least that issue. Continue reading this entry